MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® COMPLETE URINE COLLECTION KIT

Catalog Number 364946

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd vacutainer® complete urine collection kit had deformed tubes.There was no report of exposure, serious injury, or medical intervention.

Manufacturer Narrative

Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that a bd vacutainer® complete urine collection kit had deformed tubes.There was no report of exposure, serious injury, or medical intervention.

• Brand Name: BD VACUTAINER® COMPLETE URINE COLLECTION KIT
• Type of Device: COLLECTION KIT
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7985187
• MDR Text Key: 124554624
• Report Number: 1917413-2018-03700
• Device Sequence Number: 1
• Product Code: KDT
• UDI-Device Identifier: 00382903649464
• UDI-Public: 382903649464
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 364946
• Device Lot Number: 8059545
• Date Manufacturer Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other